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CTRI Number  CTRI/2025/04/084519 [Registered on: 09/04/2025] Trial Registered Prospectively
Last Modified On: 08/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized Factorial Trial 
Public Title of Study   A Study to Help Doctors Know in Advance If Spinal Anesthesia Will Be Challenging 
Scientific Title of Study   Predicting score for difficult subarachnoid block 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JUNEJO PK 
Designation  Junior resident 
Affiliation  Goa medical college 
Address  Goa medical college Anesthesia department Division -Anesthesia Room number 4

North Goa
GOA
403202
India 
Phone  8073373284  
Fax    
Email  junejo.000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sharmila borkar 
Designation  Associate professor  
Affiliation  Goa Medical college 
Address  Goa medical college Anesthesia department Division -anesthesia Room number 4 Goa

North Goa
GOA
403202
India 
Phone  9922851257  
Fax    
Email  drsharmila_borkar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Sharmila borkar 
Designation  Associate professor  
Affiliation  Goa Medical College  
Address  Goa medical college Anesthesia department Depart Division- anesthesia Room number 4 Goa

North Goa
GOA
403202
India 
Phone  9922851257  
Fax    
Email  drsharmila_borkar@yahoo.com  
 
Source of Monetary or Material Support  
Goa medical college Bambolim Goa ,India Pin 403202 
 
Primary Sponsor  
Name  JUNEJO 
Address  Goa medical college Bambolim Goa India Pin 403202 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sharmila Borkar  Hospital   Goa Medical College Anesthesia department Depart Division- anesthesia Room number 4 Goa
North Goa
GOA 		 9922851257

drsharmila_borkar@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutionalethicscommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Posted for surgery 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Subarachnoid block  A clinical scoring system will be used to assess and predict the likelihood of difficulty in performing subarachnoid block in adult patients. This includes pre-anesthesia evaluation using parameters such as spine anatomy, BMI and age . Routine spinal anesthesia will be performed as per standard hospital protocol. 
Comparator Agent  Subarachnoid block  The prediction score will be compared against the real-time difficulty experienced during the subarachnoid block procedure. Difficulty will be assessed based on predefined criteria such as number of attempts, change of intervertebral space, or need for expert intervention.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All posted for routine elective surgery 
 
ExclusionCriteria 
Details  Pregnancy
age less than 18
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation between predicted difficulty score and actual difficulty experienced during subarachnoid block  Predicted score: Pre-procedure (before spinal anesthesia)
Actual difficulty assessment: Intra-procedure (during spinal anesthesia)


 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes include the number of attempts, time taken, need to change intervertebral space or anaesthesiologist   These will be recorded during & with in one hour after the spinal anesthesia procedure. 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   19/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [junejo.000@gmail.com].

  6. For how long will this data be available start date provided 26-03-2025 and end date provided 29-07-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Subarachnoid block (spinal anesthesia) is a commonly performed regional anesthetic technique. However, in certain patients, the procedure can be technically difficult, leading to multiple attempts, patient discomfort, delays, and increased complication risk. Identifying such patients beforehand can help improve planning and patient safety.

The purpose of this study is to develop or validate a clinical scoring system to predict the likelihood of difficulty in performing subarachnoid block. By assessing patient-related factors before the procedure and correlating them with actual procedural difficulty, the study aims to assist anesthesiologists in anticipating challenges and improving procedural outcomes.

 
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